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白介素17(人类rDNA衍生)(WHO参考试剂)
  【编号】:NIBSC01/420

  【名称】:白介素17(人类rDNA衍生)(WHO参考试剂)

  【规格】:1个

  【价格】:2600元

  白介素17(人类rDNA衍生)(WHO参考试剂)

  编号:NIBSC01/420
  英文:Interleukin-17 (Human rDNA derived)(WHO Reference Reagent)
  标准类型:国际参考试剂
  规格:1个 
  描述:1. INTENDED USE
This standard is the primary biological standard for Interleukin-17 (IL-17).
2. CAUTION
This preparation is not for administration to humans or animals in
the human food chain.
The preparation contains material of human origin, and either the final
product or the source materials, from which it is derived, have been
tested and found negative for HBsAg, anti-HIV and HCV RNA. As with
all materials of biological origin, this preparation should be regarded as
potentially hazardous to health. It should be used and discarded
according to your own laboratory's safety procedures. Such safety
procedures should include the wearing of protective gloves and
avoiding the generation of aerosols. Care should be exercised in
opening ampoules or vials, to avoid cuts.
3. UNITAGE
In a limited collaborative study, the preparation coded 01/420 was found
to possess IL-17 activity comparable to in-house standards, based on its
ability to stimulate release of IL-6 from human dermal fibroblasts or a
fibroblast cell line. The preparation is therefore established as the WHO
Reference Reagent for IL-17 for bioassay, with an assigned potency of
10,000 Units per ampoule. It should be noted that this assigned potency
is arbitrary, and does not reflect any pre-existing units for IL-17 activity,
and it does not establish continuity with any pre-existing in-house
standards. Users of the material should also note that the preparation
01/420 may be suitable to serve as a standard for the bioassay of IL-17
using assay methods based on other biological activities of IL-17, but
such applications have not been demonstrated for 01/420, and would
require appropriate validation. Users who have data supporting the use of
this preparation in another biological assay are encouraged to contact
NIBSC.
The preparation 01/420 was also shown to possess immunoactivity
comparable to in-house IL-17 standards, in a limited number of in-house
immunoassay systems. Whilst 01/420 is not formally established as an
immunoassay standard, it may be suitable as an immunoassay standard,
subject to appropriate validation. Users should note particularly that the
immunological stability of this preparation, stability after freezing and
thawing of the reconstituted ampoule contents has not been
demonstrated for all immunoassay systems, and such studies should be
undertaken by the user as part of such immunoassay application
validation.
4. CONTENTS
Country of origin of biological material: United Kingdom.
Each ampoule contains the residue after freeze-drying of 1.0 ml of a
solution comprising:
IL-17 approximately 1 microgram
9.0 mg sodium chloride
1.0 mg trehalose
2.0 mg human serum albumin
The IL-17A protein was expressed in E.coli
5. STORAGE
For economy of use, it is recommended that the solution be sub divided
into several small aliquots and stored at -40ºC or below. Avoid repeated
freezing/thawing. Unopened ampoules should be stored at –20ºC.
Please note: because of the inherent stability of lyophilized material,
NIBSC may ship these materials at ambient temperature.
6. DIRECTIONS FOR OPENING
DIN ampoules have an 'easy-open' coloured stress point, where the
narrow ampoule stem joins the wider ampoule body. Various types of
ampoule breaker are available commercially. To open the ampoule, tap
the ampoule gently to collect material at the bottom (labelled) end and
follow manufactures instructions provided with the ampoule breaker.
7. USE OF MATERIAL
No attempt should be made to weigh out any portion of the freeze-dried
material prior to reconstitution
Dissolve the total contents of the ampoule in 1.0 ml of sterile distilled water.
This solution will contain IL-17 at a concentration of 10,000 Units/ml. Use
carrier protein where extensive dilution is required.
8. STABILITY
Reference materials are held at NIBSC within assured, temperaturecontrolled
storage facilities and they should be stored on receipt as
indicated on the label. It is the policy of WHO not to assign an expiry date
to their international reference materials. Accelerated degradation studies
have indicated that this material is suitably stable, when stored at -20ºC
or below, for the assigned values to remain valid until the material is
withdrawn or replaced. These studies have also shown that the material
is suitably stable for shipment at ambient temperature without any effect
on the assigned values. Once reconstituted, diluted or aliquoted, users
should determine the stability of the material according to their own
method of preparation, storage and use. Users who have data
supporting any deterioration in the characteristics of any reference
preparation are encouraged to contact NIBSC.
9. REFERENCES
The standard was produced under WHO guidelines cited in the WHO
Technical Reports Series, No.927, 2005
For details of the collaborative study report, please refer to WHO document
reference WHO/BS/06.2039
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